PBMT for the Prevention of CIPN
Keywords
Abstract
Dates
| Last Verified: | 06/30/2019 |
| First Submitted: | 12/29/2017 |
| Estimated Enrollment Submitted: | 12/29/2017 |
| First Posted: | 01/04/2018 |
| Last Update Submitted: | 07/24/2019 |
| Last Update Posted: | 07/25/2019 |
| Actual Study Start Date: | 11/12/2017 |
| Estimated Primary Completion Date: | 12/30/2020 |
| Estimated Study Completion Date: | 12/30/2020 |
Condition or disease
Intervention/treatment
Other: photobiomodulation therapy (PBMT)
Other: Placebo group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: photobiomodulation therapy (PBMT) During photobiomodulation therapy (PBMT) or low-level laser therapy, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves | Other: photobiomodulation therapy (PBMT) Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
• The PBMT-group will receive twice-weekly laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy) |
| Placebo Comparator: Placebo group No PBMT | Other: Placebo group • The control group will undergo twice-weekly sham laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy). The laser device will be placed on the same manner and for the same period of time on the identified body sites, but the device will not be switched on. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Diagnosed with non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma - Age 18 years or above - Are planned to undergo at least 3 cycles of taxane treatment (i.e. paclitaxel or docetaxel) - Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis). - Signed informed consent Exclusion Criteria: - Have a history of neuropathy before taxane treatment due to other medical conditions: diabetes, peripheral vascular disease, HIV infection, significant degenerative or familial neurologic disorder, nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression) - Taking stable doses of medication on prescription or dietary supplements for peripheral neuropathy. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12; Patients need to agree not to initiate a new therapy two weeks before and during the study period. - Metastatic disease - Have a diagnosis of ethanol addiction or dependence within the past 10 years. - Concurrent chemotherapy with neurotoxic chemotherapeutic agents (i.e. platinum compounds or vinca alcaloids) - Severe or unstable cardio- respiratory or musculoskeletal disease |
Outcome
Primary Outcome Measures
1. The modified total neuropathy score (mTNS) [baseline]
2. The modified total neuropathy score (mTNS) [week 6]
3. The modified total neuropathy score (mTNS) [week 12]
4. The modified total neuropathy score (mTNS) [week 15]
Secondary Outcome Measures
1. Quality of life [baseline]
2. Quality of life [week 6]
3. Quality of life [week 12]
4. Quality of life [week 15]
5. Pain evaluation [baseline]
6. Pain evaluation [week 6]
7. Pain evaluation [week 12]
8. Pain evaluation [week 15]
